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regulatory affairs.

job details

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    job details

    Randstad has been given the opportunity to support one of our flagship clients in the Cosmetic space, who are currently recruiting a key position of Regulatory Affairs Project Manager, to be based in central Melbourne.

    This role gives you the opportunity for progression within this growing organisation, dealing with national and International teams, based from the client's site here in central Melbourne. Also offering the opportunity to work from home with flexibility and a package of $100-$110k + super depending on experience. The main purpose of the role is to to support with the provision of general regulatory advice in global cosmetic regulations.with key focus on -
    • Assist in the development of regulatory strategies for global product distribution
      • Keeping up to date with regulatory developments in major markets
      • Identification of regional-specific requirements for registration
      • Preparation of documentation to support the marketing authorization/product registration application
      • Development and maintenance of regulatory quality systems to support post-marketing authorization
      activities
      • Maintaining approvals by submission of annual updates and/or reports as needed
      • Support clinical staff in the design of adequate studies and gain study approval
      • Cosmetic product registrations in major markets, including EU, US, ASEAN, and Australia
      • Product life cycle and portfolio management
      • Prepare and manage product dossier or PIF including drafting and submission, for new products, license
      renewals, licensing, and advertising

    Further Key focus -Development and maintenance of regulatory quality systems
    • Dossier/PIF files management
    • Interpret global cosmetic regulations
    • Provide regulatory opinions for company’s projects to minimise regulatory risks, determine business impacts
    and ensure compliance
    • Review and approve advertisement and promotional materials
    • Provide regulatory training if needed

    About you -
    • A minimum of 3 years professional experience in pharmaceutical/cosmetic industry, with a minimum of 2
    years in regulatory affairs
    • Bachelor’s Degree in a scientific/technical/engineering discipline or equivalent required
    • Proven cosmetic product registration experience
    • Proven cosmetic product safety, claiming, quality and registration experience
    • Global Cosmetic regulatory knowledge
    • (Desirable) Formulation and regulatory experience with sun care products
    • Up-to-date knowledge of trends in skin care and cosmetics
    If this role sounds like something you'd be interested in discussing further, please reach out to me on itisan.abdi@randstad.com.au to learn more about the company and role.

    At Randstad, we are passionate about providing equal employment opportunities and embracing diversity to the benefit of all. We actively encourage applications from any background.

    Randstad has been given the opportunity to support one of our flagship clients in the Cosmetic space, who are currently recruiting a key position of Regulatory Affairs Project Manager, to be based in central Melbourne.

    This role gives you the opportunity for progression within this growing organisation, dealing with national and International teams, based from the client's site here in central Melbourne. Also offering the opportunity to work from home with flexibility and a package of $100-$110k + super depending on experience. The main purpose of the role is to to support with the provision of general regulatory advice in global cosmetic regulations.with key focus on -
    • Assist in the development of regulatory strategies for global product distribution
      • Keeping up to date with regulatory developments in major markets
      • Identification of regional-specific requirements for registration
      • Preparation of documentation to support the marketing authorization/product registration application
      • Development and maintenance of regulatory quality systems to support post-marketing authorization
      activities
      • Maintaining approvals by submission of annual updates and/or reports as needed
      • Support clinical staff in the design of adequate studies and gain study approval
      • Cosmetic product registrations in major markets, including EU, US, ASEAN, and Australia
      • Product life cycle and portfolio management
      • Prepare and manage product dossier or PIF including drafting and submission, for new products, license
      renewals, licensing, and advertising

    Further Key focus -Development and maintenance of regulatory quality systems
    • Dossier/PIF files management
    • Interpret global cosmetic regulations
    • Provide regulatory opinions for company’s projects to minimise regulatory risks, determine business impacts
    and ensure compliance
    • Review and approve advertisement and promotional materials
    • Provide regulatory training if needed

    About you -
    • A minimum of 3 years professional experience in pharmaceutical/cosmetic industry, with a minimum of 2
    years in regulatory affairs
    • Bachelor’s Degree in a scientific/technical/engineering discipline or equivalent required
    • Proven cosmetic product registration experience
    • Proven cosmetic product safety, claiming, quality and registration experience
    • Global Cosmetic regulatory knowledge
    • (Desirable) Formulation and regulatory experience with sun care products
    • Up-to-date knowledge of trends in skin care and cosmetics
    If this role sounds like something you'd be interested in discussing further, please reach out to me on itisan.abdi@randstad.com.au to learn more about the company and role.

    At Randstad, we are passionate about providing equal employment opportunities and embracing diversity to the benefit of all. We actively encourage applications from any background.